Breast implant spacers for the treatment of periprosthetic breast implant infections

ABSTRACT

The present disclosure provides improved devices and methods to treat periprosthetic breast implant infections.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is continuation application of U.S. patentapplication Ser. No. 13/458,647, filed on Apr. 27, 2012, which isincorporated herein by reference in its entirety.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable.

THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT

Not Applicable.

INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC

Not Applicable.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present disclosure generally concerns devices and methods for thetreatment of infections arising from breast implants.

2. Description of the Related Art

Approximately one in nine women in the United States are diagnosed withbreast cancer each year, and approximately 90,000 women per year chooseto undergo breast reconstruction utilizing tissue expansion followed byinsertion of a permanent breast implant. Unfortunately, approximately20-24% of these reconstructions will be complicated by development of aperiprosthetic implant infection. In addition, in the year 2010approximately 270,000 women underwent cosmetic breast augmentation, andapproximately 2.0-2.5% are expected to develop a periprosthetic implantinfection. Periprosthetic infection of an expander-implant breastreconstruction or augmented breast is considered a devastatingcomplication.

A number of recent protocols have been described to attempt to preventinfection in conjunction with the initial breast implant procedure. Suchprotocols include extensive irrigation of the implant location withantibiotics during the implant procedure (United States PatentApplication Publication No. US 2011/0137412 A1), coating the implantwith antibiotics (United States Patent Application Publication No. US2010/0198350 A1; United States Patent Application Publication No. US2011/0106248 A1; United States Patent Application Publication No. US2011/0262511 A1), and using implants that are surrounded by anantibiotic-eluting pocket (United States Patent Application PublicationNo. US 2011/0160854 A1) or biodegradable mesh (United States PatentApplication Publication No. US 2010/0168808 A1; United States PatentApplication Publication No. US 2011/0082545 A1). Additionally, in casesof reconstructive breast implantation, treatment with antibiotics duringtissue expansion (United States Patent Application Publication No. US2011/0137244 A1). However, even though such protocols can reduce theincidence of periprosthetic breast implant infections, they are not 100%effective.

Initial attempts to treat periprosthetic breast implant infections usingantibiotics alone were somewhat effective, but was associated withdevelopment of a hard, painful reconstructed breast (symptomaticcapsular contracture) in up to 68% of cases (Courtiss, et al., Plast.Reconstr. Surg. 63:812-816, 2003).

Current treatment protocols for periprosthetic breast implant infectionsemploy the use of oral and intravenous antibiotic therapy often followedby surgical debridement and implant exchange, also known as implantsalvage (Yii and Khoo, Plast. Reconstr. Surg. 111:1087-1092, 2003;Spear, et al., Plast. Reconstr. Surg. 113:1634-1644, 2004; Spear andSeruya, Plast. Reconstr. Surg. 125:1074-1084, 2010; Bennett, et al., J.Plast. Reconstr. Aesthet. Surg. 64:1270-1277, 2011). This treatmentregimen can prove successful for managing mild infections; however, ithas a success rate of approximately 25-30% when it is utilized to treatmore severe infections.

A recent report details the addition of lyophilized collagen matriximpregnated with gentamicin upon implant salvage (Lapid, J. Plast.Reconstr. Aesthet. Surg. 64:e313-316, 2011), with subsequent absorptionof the collagen carrier. However, collagen is a major component of scartissue, and the collagen matrix could act as a scaffold for dense scarformation, which would lead to the development of a hard, painfulreconstructed breast. Furthermore, once the antibiotic has beenoffloaded the matrix could act as a potential media for bacterialgrowth.

Failure of the antibiotic therapy-implant exchange protocol requiresremoval of the implant for 6-12 months. This often produces contraction(loss of domain) of the reconstructed breast requiring that the ratherlengthy and painful tissue expansion process be repeated before a newpermanent implant is inserted. Removal of the implant from the augmentedbreast can produce contracture and soft tissue distortion, impairing theability to achieve a cosmetically acceptable re-augmentation aftercompletion of the waiting period.

Therefore improved devices and methods to treat periprosthetic breastimplant infection would represent a significant advance in the art.

BRIEF SUMMARY OF THE INVENTION

The present disclosure provides improved devices and methods to treatperiprosthetic breast implant infections. In addition to improvedpatient outcome, both physically and psychologically, the benefits ofthe presently described devices and methods include reduced costs forpatients and insurance companies alike.

The present disclosure first provides a breast implant spacer comprisinga cement and an antibiotic, antifungal, bacteriostatic or bacteriocidalagent, or any combination thereof. As the breast implant spacer isdesigned to be inserted in place of the original breast implant, it isdesigned to substantially resemble the original breast implant. In otherwords, the breast implant spacer is designed to have a comparable volumeand/or a comparable shape to the original breast implant.

The breast implant spacer can comprise a plurality of segments. In anexemplary embodiment, the segments are connected by at least a firstpivot pin. The at least a first pivot pin can comprise a number ofdifferent materials, including, but not limited to, a polymer, anacrylic cement (which can be loaded with an antibiotic), a metal, or acombination thereof. Polymers suitable for use in manufacture of the atleast a first pivot pin include, but are not limited to, ultra-highmolecular weight polyethylene, high density polyethylene, acetalhomopolymer, polyetheretherketone, acetal polyoxymethylene copolymer,acrylonitrile butadiene styrene, fluorinated ethylene propylene,polytetrafluoroethylene linked to mica, polytetrafluoroethylene,ethylene tetrafluoroethylene, polyphenylene sulfide, polyphenylsulfone,polyethyleneimine, polysulfone, polyethersulfone, polycarbonate,poly(p-phenylene oxide), or a combination thereof. Metals suitable foruse in manufacturing the pivot pin include, but are not limited to,stainless steel, titanium, cobalt chromium, or a combination thereof.The segments can also be connected by a first pivot pin and a secondpivot pin, which can be made from the same material or differentmaterials. The breast implant spacer can also comprise a suture hole.When the breast implant spacer comprises a plurality of segments, atleast two of the plurality of segments can comprise a suture hole.

The segments can also be connected by a wire, which can comprise, forexample, stainless steel, DFT®, titanium or a titanium alloy, tantalum,a copper-manganese, copper-nickel, nickel-chromium or quaternaryresistance alloy, a mechanical alloy, an austenitic nickel-chromiumbased superalloy, a HASTELLOY® corrosion-resistant superalloy, or ashape-memory alloy, including, but not limited to, acopper-zinc-aluminum-nickel, copper-aluminum-nickel, or nickel-titaniumshape-memory alloy. The segments can also be connected by a spring,which can comprise, for example, stainless steel, DFT®, titanium or atitanium alloy, tantalum, a copper-manganese, copper-nickel,nickel-chromium or quaternary resistance alloy, a mechanical alloy, anaustenitic nickel-chromium based superalloy, a HASTELLOY®corrosion-resistant superalloy, or a shape-memory alloy, including, butnot limited to, a copper-zinc-aluminum-nickel, copper-aluminum-nickel,or nickel-titanium shape-memory alloy.

In certain embodiments, the breast implant spacer further comprises atemplate. The template can comprise a biocompatible polymer and/or ametal. Biocompatible polymers suitable for use in preparing the templateinclude, but are not limited to, ultra-high molecular weightpolyethylene, high density polyethylene, acetal homopolymer,polyetheretherketone, acetal polyoxymethylene copolymer, acrylonitrilebutadiene styrene, fluorinated ethylene propylene,polytetrafluoroethylene linked to mica, polytetrafluoroethylene,ethylene tetrafluoroethylene, polyphenylene sulfide, polyphenylsulfone,polyethyleneimine, polysulfone, polyethersulfone, polycarbonate,poly(p-phenylene oxide), or a combination thereof. Metals suitable foruse in the preparation of the template include, but are not limited to,stainless steel, titanium, cobalt chromium, or a combination thereof.

The breast implant spacer can be created from a mold, which cancomprise, for example, polyetheretherketone, a medical grade plastic orsilicone, ultra-high molecular weight polyethylene, high densitypolyethylene, acetal homopolymer, acetal polyoxymethylene copolymer, ora combination thereof. The breast implant spacer can also be createdfrom an injectable mold, which can comprise, for example, a medicalgrade plastic or silicone.

The breast implant spacer can comprise a poly-methyl-methacrylatecement, a methyl-methacrylate-styrene copolymer cement, or amethyl-methacrylate-methyl acrylate cement. In general, the antibiotic,antifungal, bacteriostatic or bacteriocidal agents used in the breastimplant spacer do not degrade due to the heat generated upon the cementsetting. Suitable antibiotic, antifungal, bacteriostatic orbacteriocidal agents for use in the presently described breast implantspacers include, but are not limited to, vancomycin, tobramycin,voriconazole, gentamicin, erythromycin, oxacillin, cloxacillin,methicillin, lincomycin, ampicillin, colistin, clindamycin, acephalosporin, amphotericin B, fluconazole, copper-nitride, metallicsilver, or any combination thereof.

The present disclosure also provides a breast implant spacer comprisingplurality of segments, each of said segments comprising apoly-methyl-methacrylate cement and vancomycin, tobramycin,voriconazole, or any combination thereof, said plurality of segmentsconnected by a first pivot pin and a second pivot pin, wherein thespacer is designed to approximate a volume and a shape of a breastimplant.

The present disclosure further provides a breast implant spacercomprising plurality of segments, each of said segments comprising apoly-methyl-methacrylate cement and vancomycin, tobramycin,voriconazole, or any combination thereof, said plurality of segmentsconnected by a spring, wherein the spacer is designed to approximate avolume and a shape of a breast implant.

The present disclosure additionally provides a mold for forming a breastimplant spacer, comprising a base defining a concave indentation and aconvex plunger comprising a plurality of projections, the moldapproximating or substantially comparable to the volume and/or the shapeof a breast implant. Furthermore, the present disclosure provides aninjectable mold for forming a breast implant spacer, comprising an outershell comprising a convex first portion and a flat second portion,having a plurality of fill ports, a plurality of air efflux ports, and aplurality of septal anchors, and an internal bladder having a liquidfill port, said plurality of septal anchors stabilizing said internalbladder within said convex first portion and said flat second portion,the injectable mold approximating or substantially comparable to thevolume and the shape of a breast implant.

The present disclosure also provides a method of making an antibioticbreast implant spacer, comprising introducing a mixture of a cement andan antibiotic into a mold that approximates or is comparable to thevolume and the shape of a breast implant, allowing the mixture to set toform the antibiotic breast implant spacer, and removing the antibioticbreast implant spacer from the mold. The mold can comprise, for example,polyetheretherketone, a medical grade plastic or silicone, ultra-highmolecular weight polyethylene, high density polyethylene, acetalhomopolymer, acetal polyoxymethylene copolymer, or a combinationthereof. The mold can also be an injectable mold, which can comprise,for example, a medical grade plastic or silicone, or a combinationthereof. The antibiotic breast implant spacer can also be cut intosegments.

The present disclosure further provides a method of treating a breastimplant infection in a patient in need of such treatment, comprisingreplacing the breast implant with a breast implant spacer comprising acement and an antibiotic, wherein the spacer is designed to approximateor be comparable to a volume and a shape of the breast implant.

Throughout this disclosure, unless the context dictates otherwise, theword “comprise” or variations such as “comprises” or “comprising,” isunderstood to mean “includes, but is not limited to” such that otherelements that are not explicitly mentioned may also be included.Further, unless the context dictates otherwise, use of the term “a” maymean a singular object or element, or it may mean a plurality, or one ormore of such objects or elements.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The following drawings form part of the present specification and areincluded to further demonstrate certain aspects of the presentinvention. The invention may be better understood by reference to one ormore of these drawings in combination with the detailed description ofspecific embodiments presented herein.

FIG. 1. A side view of an embodiment of a four segment articulatedantibiotic spacer of the present disclosure.

FIG. 2. A top view of an embodiment of a six segment articulatedantibiotic spacer of the present disclosure.

FIG. 3. A perspective view of an embodiment of a segmented, springloaded antibiotic spacer of the present disclosure.

FIG. 4. A perspective view of an embodiment of a mold base and moldinsert used to form an antibiotic spacer of the present disclosure.

FIG. 5. A side view of an embodiment of a mold base and a mold spacerused to form an antibiotic spacer of the present disclosure.

FIG. 6. A top view of an embodiment of a mold base used to form anantibiotic spacer of the present disclosure.

FIG. 7. A side view of an embodiment of a mold base used to form anantibiotic spacer of the present disclosure.

FIG. 8. A top view of an embodiment of an injectable mold used to forman antibiotic spacer of the present disclosure.

FIG. 9. A side view of an embodiment of an injectable mold used to forman antibiotic spacer of the present disclosure.

DETAILED DESCRIPTION OF THE INVENTION

The present disclosure is directed to improved devices and methods totreat periprosthetic breast implant infections. The present disclosurespecifically addresses the formulation, preparation and use ofantibiotic spacers that approximate the volume and shape of the existingbreast implant. In general the antibiotic spacers comprise a cement,such as a bone cement, and an antibiotic, antifungal, bacteriostatic orbacteriocidal agent, or any combination thereof. In certain embodimentsthe antibiotic spacers comprise a plurality of connected segments. Infurther embodiments the antibiotic spacers could be formed by coating atleast a portion of metallic or plastic template with a cement and anantibiotic, antifungal, bacteriostatic or bacteriocidal agent.

FIG. 1 shows a side view of one embodiment of an antibiotic spacer 100of the present disclosure. In this embodiment antibiotic spacer 100 iscomprised of four segments, 101, 102, 103 and 104, which are connectedby pivot pins 110 and 111 such that the segments 101, 102, 103 and 104can rotate on the pivot pins 110 and 111 to form a generally circularshape (see FIG. 2). Each of segments 101, 102, 103 and 104 are comprisedof a cement, such as a bone cement, that is impregnated with one or moreantibiotics. The skilled artisan will appreciate that in suchembodiments the number of segments is not important, and can vary from 2to 8 or more (not shown) depending upon the particular requirements ofthe spacer. In addition, the segments can be connected with a singlepivot pin (not shown). The dimensions of the antibiotic spacer can vary,depending upon the particular application, but in general the diametercan range between about 9 cm and about 16 cm, the height (or projection)can range between about 3 cm and about 8 cm, and the thickness can rangebetween about 5 mm and about 1 cm.

A number of different materials can be used to fabricate pivot pins 110and 111, including, but not limited to, a polymer such as ultra-highmolecular weight polyethylene, high density polyethylene, acetalhomopolymer (DELRIN®), polyetheretherketone (PEEK), acetalpolyoxymethylene (POM) copolymer (CELCON®, ULTRAFORM®, ACETRON® GP),acrylonitrile butadiene styrene (ABS), fluorinated ethylene propylene(FEP), polytetrafluoroethylene (PTFE) linked to mica (FLUOROSINT®), PTFE(TEFLON®), ethylene tetrafluoroethylene (ETFE; TEFZEL®), polyphenylenesulfide (PPS; FORTRON®), polyphenylsulfone (PPSU; RADEL®),polyethyleneimine (PEI), polysulfone (PSU; ULTRASON® S),polyethersulfone (PES; ULTRASON® E), polycarbonate (PC),poly(p-phenylene oxide) (PPO), acrylic cement (which is certaininstances can be loaded with an antibiotic), or metal, such as stainlesssteel, titanium or cobalt chromium, or any combination thereof.

A number of different cements or combination of cements can be used tofabricate the antibiotic spacer. In general, such cements or combinationof cements are solid enough to maintain the shape of the breast implantthroughout most or all of the procedure, while at the same time porousenough to allow a sufficient or therapeutically effective amount ofantibiotic (or combination of antibiotics) to diffuse from the cement totreat or cure the infection. For example cements that can be usedinclude, but are not limited to, bone cements, such as apoly-methyl-methacrylate (PMMA) cement, including those produced underthe trade names Generation 4™, CMW1, CMW2, CMW3, Zimmer Dough Type,Zimmer LVC, SMARTSET® MV, SMARTSET® GMV, or SMARTSET® GHV, a MMA-styrenecopolymer cement, including those produced under the trade namesStryker® Simplex™ P or Zimmer OSTEOBOND®, or an MMA-methyl acrylatecopolymer cement, including those produced under trade name Cobalt™G-HV, Cobalt™ HV, or PALACOS® R.

A number of different antibiotic, antifungal, bacteriostatic orbacteriocidal agents, or any combination thereof, can be used in theantibiotic spacer. In general, such antibiotic, antifungal,bacteriostatic or bacteriocidal agents, or combination thereof, arestable enough to withstand the heat generated during the curing of thecement (or combination of cements) used to fabricate the antibioticspacer. The choice of antibiotic, antifungal, bacteriostatic orbacteriocidal agent for the spacer may depend upon the source of anactual infection or potential infection, and include, but is not limitedto, vancomycin, tobramycin, voriconazole gentamicin, erythromycin,oxacillin, cloxacillin, methicillin, lincomycin, ampicillin, colistin,clindamycin, a cephalosporin, amphotericin B, fluconazole,copper-nitride, metallic silver, or any combination thereof.

FIG. 2 shows a top view of another embodiment of an antibiotic spacer200 of the present disclosure. In this embodiment antibiotic spacer 200is comprised of six segments, 201, 202, 203, 204, 205 and 206, which areconnected by pivot pin 210 such that the segments 201, 202, 203, 204,205 and 206 can rotate on the pivot pin 210 to form a generally circularshape. Also shown are suture holes 221, 222, 223 and 224, which areconnected by sutures 225 and 226. The skilled artisan will appreciatethat in such embodiments the number of suture holes is not important,and can vary from 1 to 4 or more (not shown) depending upon theparticular requirements of the spacer. In addition, the suture holes canbe connected with wire or any other suitable material (not shown).

FIG. 3 shows a perspective view of another embodiment of an antibioticspacer 300 of the present disclosure. In this embodiment antibioticspacer 300 is comprised of a plurality of segments 301 that areconnected by a spring 310. The skilled artisan will appreciate that insuch embodiments the size and number of segments 301, the total lengthof the spring 310, as well as the distance between the segments 301 onthe spring 310 can vary as described herein above depending upon theparticular needs of the patient. In certain embodiments (not shown) thesegments 301 can be connected by one or more wires, for example wirescomprising stainless steel, DFT®, titanium or a titanium alloy,tantalum, a copper-manganese, copper-nickel, nickel-chromium orquaternary resistance alloy (i.e., BALCO® 120, INCOLOY® alloy 800), amechanical alloy (i.e., MONEL® 400), an austenitic nickel-chromium basedsuperalloy (i.e., ICONEL®) or a HASTELLOY® corrosion-resistantsuperalloy, or wires fabricated from a shape-memory alloy. The mostcommon types of shape-memory alloys are the copper-zinc-aluminum-nickel,copper-aluminum-nickel, and nickel-titanium (NiTi) alloys, butshape-memory alloys can also be created by alloying zinc, copper, goldand iron.

FIG. 4 shows a perspective view of an embodiment of a mold base 400 andmold plunger 401 used to form an embodiment of an antibiotic spacer ofthe present disclosure. In this embodiment the mold base 400 has acut-out or indentation having a concave surface 400 a that approximatesthe shape of the breast implant (not shown) from the patient, and themold plunger 401 comprises a handle 402, a head 403, and a plurality ofprojections 404 connected to the head 404, which can vary in lengthdepending upon the desired thickness of the antibiotic spacer. To forman antibiotic spacer using the mold shown in FIG. 4, the desired amountof a mixture of cement and antibiotic(s) (not shown) is poured onto theconcave surface 400 a of the mold base 400 to reach the desiredthickness of the antibiotic spacer, and the mold plunger 401 is insertedinto the cement/antibiotic(s) mixture. Once the cement/antibiotic(s)mixture hardens, cures or sets to form the antibiotic spacer, theplunger 401 is removed from the antibiotic spacer, and the antibioticspacer is removed from the concave surface 400 a of the mold base 400.In certain embodiments the antibiotic spacer thus formed can be cut intoa plurality of segments prior to use.

Any suitable material can be used to form the mold base 400 and plunger401, including, but not limited to, medical grade plastic or silicone,such as DOW CORNING® SILASTIC® Q7-4780 or any other 80 durometersilicone, ultra-high molecular weight polyethylene, high densitypolyethylene, PEEK, acetal homopolymer (DELRIN®), or acetalpolyoxymethylene (POM) copolymer (CELCON®, ULTRAFORM®, ACETRON® GP). Ingeneral the material used to form the mold base 400 and plunger 401should be flexible to ease removal of the hardened or cured antibioticspacer, but solid enough to maintain its shape when thecement/antibiotic mixture is added to the mold base 400, and the plunger401 is inserted into the cement/antibiotic mixture. In addition thematerial should not react adversely with the cement/antibiotic mixture,or cause breakdown of the cement or the antibiotic in the mixture.

FIG. 5 shows a side view of the embodiment of a mold base 400 and a moldplunger 401 shown in FIG. 4, which can be used to form an embodiment ofan antibiotic spacer of the present disclosure. Once again, the moldbase 400 has a concave surface 400 a that approximates the shape of thebreast implant (not shown) from the patient, and the mold plunger 401comprises a handle 402, a head 403, and a plurality of projections 404connected to the head 404, which can vary in length depending upon thedesired thickness of the antibiotic spacer.

FIG. 6 shows a top view of an embodiment of a mold base 500 used to forman embodiment of an antibiotic spacer of the present disclosure. Themold base 500 defines a cut-out portion 500 a, which in this embodimentis generally circular in shape. In other embodiments (not shown) thecut-out portion can have a generally triangular, square, or rectangularshape, or any other shape desired to construct an antibiotic spacer ofthe present disclosure. The mold base 500 also comprises a plurality (inthis embodiment seven) pegs or projections 501, which are used to formholes for sutures or wires. The skilled artisan will appreciate that insuch embodiments the number of pegs or projections 501 is not important,and can vary from 0, 1, 2, 3, 4, 5 or 6 or more (not shown) dependingupon the particular requirements of the spacer. To form an antibioticspacer using the mold shown in FIG. 6, the desired amount of a mixtureof cement and antibiotic(s) (not shown) is poured into the cut-outportion 500 a of the mold base 500 to reach the desired thickness of theantibiotic spacer. Once the cement/antibiotic(s) mixture hardens, curesor sets to form the antibiotic spacer, the antibiotic spacer is removedfrom the cut-out portion 500 a of the mold base 500. In certainembodiments the antibiotic spacer thus formed can be cut into aplurality of segments prior to use.

FIG. 7 shows a side view of an embodiment of a mold base used to form anantibiotic spacer of the present disclosure. Once again, the mold base500 has a cut-out portion 500 a and a plurality of pegs or projections501. Although the bottom of the cut-out portion 500 a is flat in thisembodiment, the bottom can be concave in further embodiments of thedisclosure (not shown).

FIG. 8 shows a top view of an embodiment of an injectable mold 600 usedto form an embodiment of an antibiotic spacer of the present disclosure.Mold 600 comprises two threaded injection/fill ports 601 two air effluxports 602 and a fill port 603 with a fitting 604 (in this embodiment aluer-lock fitting) that is connected to the internal bladder (not shownin FIG. 8; see FIG. 9). This embodiment of the injectable mold 600 isgenerally circular in shape, although in alternative embodiments (notshown) the injectable mold can generally triangular, square orrectangular in shape, or any other desired shape. Any suitable materialcan be used to form the injectable mold 600, including, but not limitedto, medical grade plastic or silicone, such as DOW CORNING® SILASTIC®Q7-4780 or any other 80 durometer silicone.

FIG. 9 shows a side view of the embodiment of the injectable mold shownin FIG. 8, which can be used to form an embodiment of an antibioticspacer of the present disclosure. Once again mold 600 comprises twothreaded injection/fill ports 601 two air efflux ports 602 and a fillport 603 with a fitting 604 (in this embodiment a luer-lock fitting)that is connected to the internal bladder 606. Internal bladder can befilled with any suitable material to define the shape of the antibioticspacer, including, but not limited to, water, saline, silicone, air ornitrogen. Also shown in FIG. 9 are septations 605 that prevent movementof the internal bladder 606 with respect to the mold 600. To form anantibiotic spacer using the mold 600, the desired amount of a mixture ofcement and antibiotic(s) (not shown) is poured or pumped into one of theinjection/fill ports 601, and fluid or gas is added to the internalbladder 606 to reach the desired thickness of the antibiotic spacer.Once the cement/antibiotic(s) mixture hardens, cures or sets to form theantibiotic spacer, the antibiotic spacer is removed from the mold 600 bysharply incising the silicone outer layer, leaving the inner bladderintact. In certain embodiments the antibiotic spacer thus formed can becut into a plurality of segments prior to use.

The following example is included to demonstrate preferred embodimentsof the invention. It should be appreciated by those of skill in the artthat the techniques disclosed in the example which follows representtechniques discovered by the inventor to function well in the practiceof the invention, and thus can be considered to constitute preferredmodes for its practice. However, those of skill in the art should, inlight of the present disclosure, appreciate that many changes can bemade in the specific embodiments which are disclosed and still obtain alike or similar result without departing from the spirit and scope ofthe invention. The present invention is not to be limited in scope bythe specific embodiments described herein, which are intended as singleillustrations of individual aspects of the invention, and functionallyequivalent methods and components are within the scope of the invention.Indeed, various modifications of the invention, in addition to thoseshown and described herein, will become apparent to those skilled in theart from the foregoing description. Such modifications are intended tofall within the scope of the appended claims.

Example 1

Antibiotic impregnated spacers provide a new and effective method fortreating periprosthetic breast implant infections. The patient isreturned to the operating room for removal of the infected implant anddebridement. An antibiotic impregnated spacer fashioned to replicate theshape and volume of the removed breast implant is inserted. The spaceris composed of polymethymethacrylate and contains all or combinations ofvancomycin, tobramycin and voriconazole. After the implant is insertedthe access incision is closed. Over a period of 4 weeks the implant willrelease its antibiotic load achieving local concentrations up to andexceeding 100 times the MIC (mean inhibitory concentration). Thesupra-physiologic antibiotic concentration is highly bactericidal yetproduces minimal systemic absorption avoiding nephrotoxicity andototoxicity. In addition to managing local infection the spacermaintains the shape and volume of the breast avoiding the need forrepeat expansion in the reconstructed breast and reducing the potentialfor disfiguring contracture in cases of cosmetic augmentation. Thespacer is used in conjunction with systemic antibiotic therapy. After a6-12 week period the patient is returned to the operating room forremoval of the spacer and insertion of a permanent breast implant.

A female who underwent bilateral simple mastectomy followed byuncomplicated expander-implant breast reconstruction was chosen to testthe antibiotic impregnated spacer. Fourteen months after the initialsurgery the patient underwent bilateral nipple reconstructioncomplicated by development of swelling, pain and erythema of the rightbreast. She was returned to the operating room where irrigation anddebridement was performed. Cultures were obtained and the originalimplant was cleansed and replaced. Operative cultures demonstratedMethocillin Resistant Staphlococcus Auerus (MRSA) and she received acourse of culture specific intravenous antibiotics. Despite thisintervention the infection recurred and she was returned to theoperating room for removal of the implant, debridement and insertion ofan antibiotic spacer containing vancomycin and tobramycin. Repeatcultures again demonstrated MRSA. She received a short course ofintravenous antibiotics followed by a 4 week course of oral antibiotics.During the 7^(th) postoperative week the patient was returned to surgeryfor removal of the spacer and insertion of a permanent breast implant.The patient has been followed for 18 months and no sign of recurrentinfection or capsular contraction has developed. The overall aestheticsof the reconstruction are good and the treatment at this juncture can bedeemed a success.

All of the compositions and/or methods disclosed and claimed herein canbe made and executed without undue experimentation in light of thepresent disclosure. While the compositions and methods of this inventionhave been described in terms of preferred embodiments, it will beapparent to those of skill in the art that variations may be applied tothe compositions and/or methods and in the steps or in the sequence ofsteps of the method described herein without departing from the concept,spirit and scope of the invention. More specifically, it will beapparent that certain agents which are both chemically andphysiologically related may be substituted for the agents describedherein while the same or similar results would be achieved. All suchsimilar substitutes and modifications apparent to those skilled in theart are deemed to be within the spirit, scope and concept of theinvention as defined by the appended claims.

What is claimed:
 1. A breast implant spacer comprising a mixture of acement and an antibiotic, antifungal, bacteriostatic or bacteriocidalagent, or a combination thereof wherein the cement is formed into theshape of a breast implant and comprises a porous structure effective toallow a therapeutic amount of the antibiotic, antifungal, bacteriostaticor bacteriocidal agent, or a combination thereof to diffuse out of thespacer into contact with the surrounding tissue when the spacer isimplanted in a human during use.
 2. The breast implant spacer of claim1, wherein the spacer is designed to substantially resemble a breastimplant.
 3. The breast implant spacer of claim 1, wherein the spacer isdesigned to have a comparable volume or a comparable shape of a breastimplant.
 4. The breast implant spacer of claim 1, further comprising atemplate.
 5. The breast implant spacer of claim 4, wherein the templatecomprises a biocompatible polymer or a metal.
 6. The breast implantspacer of claim 5, wherein the template comprises a biocompatiblepolymer.
 7. The breast implant spacer of claim 6, wherein the templatecomprises ultra-high molecular weight polyethylene, high densitypolyethylene, acetal homopolymer, polyetheretherketone, acetalpolyoxymethylene copolymer, acrylonitrile butadiene styrene, fluorinatedethylene propylene, polytetrafluoroethylene linked to mica,polytetrafluoroethylene, ethylene tetrafluoroethylene, polyphenylenesulfide, polyphenylsulfone, polyethyleneimine, polysulfone,polyethersulfone, polycarbonate, poly(p-phenylene oxide), or acombination thereof.
 8. The breast implant spacer of claim 5, whereinthe template comprises a metal.
 9. The breast implant spacer of claim 8,wherein the template comprises stainless steel, titanium, cobaltchromium, or a combination thereof.
 10. The breast implant spacer ofclaim 1, wherein the breast implant spacer comprises a suture hole. 11.The breast implant spacer of claim 1, wherein the breast implant spaceris created from a mold.
 12. The breast implant spacer of claim 11,wherein the mold comprises a medical grade plastic or silicone,ultra-high molecular weight polyethylene, high density polyethylene,acetal homopolymer, acetal polyoxymethylene copolymer, or a combinationthereof.
 13. The breast implant spacer of claim 11, wherein the breastimplant spacer is created from an injectable mold.
 14. The breastimplant spacer of claim 13, wherein the injectable mold comprises amedical grade plastic or silicone.
 15. The breast implant spacer ofclaim 1, wherein the cement is a bone cement.
 16. The breast implantspacer of claim 1, wherein the cement is a poly-methyl-methacrylatecement, a methyl-methacrylate-styrene copolymer cement, or amethyl-methacrylate-methyl acrylate cement.
 17. The breast implantspacer of claim 16, wherein the cement is a poly-methyl-methacrylatecement.
 18. The breast implant spacer of claim 1, wherein saidantibiotic, antifungal, bacteriostatic or bacteriocidal agent does notdegrade upon the cement setting.
 19. The breast implant spacer of claim18, wherein the antibiotic, antifungal, bacteriostatic or bacteriocidalagent is vancomycin, tobramycin, voriconazole, gentamicin, erythromycin,oxacillin, cloxacillin, methicillin, lincomycin, ampicillin, colistin,clindamycin, a cephalosporin, amphotericin B, fluconazole,copper-nitride, metallic silver, or any combination thereof.
 20. Thebreast implant spacer of claim 19, wherein the antibiotic, antifungal,bacteriostatic or bacteriocidal agent is vancomycin, tobramycin,voriconazole, or any combination thereof.
 21. A mold for forming abreast implant spacer, comprising a base defining a concave indentationand a convex plunger comprising a plurality of projections, said moldapproximating the volume and the shape of a breast implant.
 22. Aninjectable mold for forming a breast implant spacer, comprising an outershell comprising a convex first portion and a flat second portion,having a plurality of fill ports, a plurality of air efflux ports, and aplurality of septal anchors, and an internal bladder having a liquidfill port, said plurality of septal anchors stabilizing said internalbladder within said convex first portion and said flat second portion,said injectable mold approximating the volume and the shape of a breastimplant.
 23. A method of making an antibiotic breast implant spacer,comprising introducing a mixture of a cement and an antibiotic,antifungal, bacteriostatic or bacteriocidal agent, or combinationthereof, into a mold that approximates the volume and the shape of thebreast implant, allowing the mixture to set to form the antibioticbreast implant spacer, and removing the antibiotic breast implant spacerfrom the mold and cutting the antibiotic breast implant spacer intosegments.
 24. The method of claim 23, wherein the mold comprises amedical grade plastic or silicone, ultra-high molecular weightpolyethylene, high density polyethylene, acetal homopolymer, acetalpolyoxymethylene copolymer, or a combination thereof.
 25. The method ofclaim 24, wherein the mold is an injectable mold.
 26. The method ofclaim 25, wherein the injectable mold comprises a medical grade plasticor silicone, or a combination thereof.
 27. The method of claim 23,wherein said antibiotic, antifungal, bacteriostatic or bacteriocidalagent does not degrade upon the cement setting.